Heart disease is one of the leading causes of death for elderly people. Currently, medical science cannot reverse the damage done to the cardiac muscle by heart disease. The only known solution is a heart transplant. However, the number of cardiac patients in need of a heart transplant far exceeds the limited supply of donor hearts available.
The scarcity of human hearts available for transplant, as well as the logistics necessary to undertake heart transplant surgery, make a permanently implantable cardiac assist device the only viable option for many heart patients. An aortic blood pump can be permanently surgically implanted in the wall of the aorta to augment the pumping action of the heart. The aortic blood pump is sometimes referred to as a mechanical auxiliary ventricle assist device, dynamic aortic patch, or permanent balloon pump. Alternatively, the aortic blood pump can be inserted endoscopically, and is sometimes referred to as a temporary balloon pump, or simply as a balloon pump, since extended periods of use are possible depending on the method and location of surgical insertion.
Typically, the aortic blood pump includes a flexible bladder to be inflated and deflated in a predetermined synchronous pattern with respect to the diastole and systole of the patient to elevate aortic blood pressure immediately after aortic valve closure. Inflation and deflation of the bladder can be accomplished by means of a supply tube connected to the bladder and can be connected to a percutaneous access device (PAD). The PAD can be permanently surgically implanted in a patient's body to provide a through-the-skin coupling for connecting the supply tube to an extra-corporeal fluid pressure source. Electrical leads from electrodes implanted in the myocardium are likewise brought out through the skin by means of the PAD. The “R” wave of the electrocardiograph can be employed to control the fluid pressure source to inflate and deflate the inflatable chamber in a predetermined synchronous relationship with the heart action.
The aortic blood pump acts to assist or augment the function of the left ventricle and is typically restricted to use in patients who have some functioning myocardium. The aortic blood pump does not need to be operated full time, and in fact, can be operated periodically on a scheduled on-time, off-time regimen. Typically, the patient can be at least temporarily independent of the device for periods of one to four hours or more, since the aortic blood pump does not require continuous operation.
U.S. Pat. No. 6,471,633 discloses a dynamic aortic patch with an elongate bladder having a semi-rigid shell body portion and a relatively thin membrane portion defining an inflatable chamber. At least one passage extends through the shell body defining an opening in the inner surface of the shell body. The flexible membrane can be continuously bonded to the shell body adjacent the peripheral side edge to define the enclosed inflatable chamber in communication with the passage. The membrane has a reduced waist portion defining a membrane tension zone adjacent to the opening of the passage into the chamber to prevent occluding the entrance while deflating the chamber. An outer layer can be bonded to the outer side of the semi-rigid wall portion of the aortic blood pump and cut with a freely projecting peripheral edge portion to provide a suture flange for suturing the aortic blood pump in place within an incision in the aorta.
While conventional aortic balloon pumps are well known to the art, a stable aortic blood pump implant is desirable. For example, the constant movement of blood, movement of the vessel wall and the movement of the pump itself can result in deformation of the pump and vessel damage at blood/pump and vessel/pump interface area. There is a continuing need for an aortic blood pump including a structure adapted to maintain implant stability.
Particularly needed is an aortic blood pump including a structure adapted to maintain implant stability by resisting deformation in the face of the fluid and mechanical forces to which it is exposed. Thus, it would be desirable to have an aortic blood pump with a stiffening element for resisting bending and/or flexure of the shell body portion.
Additionally, the surgical implantation of a cardiac assist device is generally complicated by suturing a pump with a generally linear shape onto a curved human aorta. Thus, there exists a need for an aortic blood pump including a structure adapted to maintain implant stability by accommodation of human aortic anatomy.